Environmental protection laws at all levels of government are concerned with contaminated medical wastes also now known as regulated medical wastes. In most jurisdictions of the civilized world, such wastes can no longer be put into the conventional channels of waste disposal. Nor can much of such wastes be reliably rendered safe and unrecognizable in a practical, discernible way at the point of use. On-site sterilization, by autoclaving, for example, of medical waste does not solve the problem because sterilization is not only labor-intensive, but subject to human error and all but impossible to verify. Also, sterilizing does not change the inherently dangerous character of sharps such as needles and scalpels, nor does it render syringe bodies unrecognizable or unusable.
Used thermoplastic hypodermic syringes are possibly the most dreaded waste of all because they are contaminated, dangerous to handle, resist decay, can float until a shore is found, and, as operative devices, are sought by the illicit drug trade. Until recently, medical facilities were required to shear off the needle part from the syringe body immediately after the injection, but this procedure was found to spread disease by means of the air-borne aerosols generated by the mechanical shearing action. Also, both the contaminated needle tip and syringe body remained to be handled and disposed of as regulated waste. Current regulations call for dropping the contaminated syringe with needle intact into a safe container, called a "sharps" box, for custom delivery to an authorized repository in a costly and dubious process known as tracking.
A state-of-the-art device destroys the needle at the point of use by passing a large current at low voltage through the needle to reduce it and all attendant contaminants at temperatures of incandescence to a minute, sterile, incinerated residue. That invention protects the nearby medical personnel and the environment but it cannot cope with scalpels, glass or the leftover hollow barrels of the syringes. Thus, the medical facility, while performing a useful service to protect its personnel and society, is left with its other contaminated "sharps" and syringe bodies to ship to a safe repository. For its otherwise worthwhile efforts, it has saved little time and little, if any, total disposal cost.
There are also in the prior art techniques for rendering sharp items less dangerous by potting in gels, hardenable resins or thermoplastics. U.S. Pat. No. 4,662,516 to Baker Sr. et al., discloses a sharps waste collection box and an unverifiable sterilizing cycle in which the wastes are first caught in a thermoplastic bag containing supplemental thermoplastic panels and then placed in an autoclave to be processed through a conventional autoclaving cycle, i.e. steam under pressure for a timed interval, typically 20-30 minutes at approximately 120.degree. C. The plastic bag and panels are shown to have melted at the autoclave temperature and are shown encapsulating at least to some extent the medical waste (a hypodermic syringe barrel and needle).
The finished product, however, remains hazardous by all applicable definitions and must therefore be handled as if it had never been treated. First, the treated waste is recognizable. Much of today's medical wastes, such as glass vials, hollow syringe needles and barrels in particular, can be buoyant in liquefied plastic; needles can in the absence of constraint project from the solidified mass making them not only recognizable but exposed and legally regulatable (even if actually sterile). The treated waste, however, is not sterile. Autoclave sterilization depends on "wet" heat reaching all microbial life for a finite period of time; shielding the waste in a plastic bag or immersing it in liquefied plastic hampers the wet or autoclave process. Thus, even more time and higher temperatures would be indicated if sterilization were to be achieved. But more important, sterilization even if performed to all applicable standards is simply not verifiable on casual (or even less casual) inspection and better, safer solutions are sought.
The present regulations for dealing with medical instrument wastes call for: 1) minimum handling at the point of use, that is the person performing the injection, for example, is expected to drop the used syringe directly into the "sharps" box; 2) containerizing the waste by means of sealed and clearly marked and regulated waste containers, and 3) either destroying on the site by licensed incineration or logging and shipping the containerized, contaminated waste to a special repository (typically a special state-of-the-art incineration station) under an umbrella of costly manifests which must circulate among the facility, the hauler and the repository and then kept available for audit for several years. The expense of this tracking procedure to society is enormous and the beaches and land fills of the world reveal the flaws in the system.
The present invention is a fresh attempt to solve the problems. Its objects and features are:
to provide a relatively inexpensive waste disposal container to receive the medical waste at the point of use; PA1 to provide a way to process and sterilize inexpensively and verifiably the contaminated contents within the container while still at the medical facility; PA1 to render the syringe bodies in the container not only unusable but unidentifiable, and unretrievable; PA1 to render the needles, the scalpels and the glass harmless against cutting or piercing personnel and to render them unrecoverable by any practical means; PA1 to provide a containerized sterilizing system which is reliable and virtually immune to human error; PA1 to provide a containerized sterilizing system which provides a biological indicator even to the casual observer whether the contents have been rendered harmless and safe; PA1 to provide a containerized medical implement waste disposal system in which the treated container and its contents do not float; PA1 to provide a reliable, relatively inexpensive method and apparatus to pretreat partial loads of medical wastes at the point of use on a day-by-day or even on-demand basis in a manner which renders the contents unusable and at least partially sterile and followed by a final sterilizing and encapsulating cycle to yield a product which can be thrown out in the ordinary channels of waste disposal; and PA1 to provide a containerized sterilizing system for medical implement waste which, if desired, lends itself to recycling.